Import Alert 66-27

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-27

Published Date: 03/18/2011

Type: DWPE

Import Alert Name:

"Detention Without Physicla Examination of Drugs from the Hauptmann Institute Vienna, Austria"

Reason for Alert:

Since August 1986, drugs from the Hauptmann Institute have been subjected to automatic detention. At that time, Karl-Gustov Hauptmann, M.D., Director of the Institute, had purchased the Longevity Institute S.A., Balboa, Republic of Panama to promote therapies to Americans and citizens from other countries who he claimed, were denied treatment essential to their health and longevity by their governments. Although many of the drugs were approved in the United States, claims were made in promotional literature distributed by the Institute that included treatment of medical conditions for which the drugs were not approved.

Through January 1987, ORL-DO had detained over 300 shipments of drugs from the Hauptmann Institute. As a result, additional drugs and promotional literature were identified.

Products mailed to individuals in the United States have been by airmail postmarked Luton, England. Mailed products may be contained in yellow padded envelopes or small brown cartons. Customs declarations of contents for these shipments have indicated "nutritional supplements". Samples induced by the U.S. Postal Service were declared as non-consumable items such as a puzzle, a telephone address book, or tankard.

ORL-DO reported that some shipments of Minoxidil had been received in unlabeled bottles. Stick on labels for Minoxidil, instructions for use, and in some cases, a prescription, had been subsequently provided by the Heitzinger Pharmacy which also uses the same mail drop address as the Hauptmann Institute.

Further, ORL-DO reported that a flyer had been distributed by The Hauptmann Institute to customers in the states of Florida and Georgia alleging that FDA had detained these drugs illegally based on "the FDA ruling that permits individuals to bring unapproved drugs into the United States for personal use". It was contended that The Hauptmann Institute had filed a formal complaint and that FDA had not yet issued a formal order regarding this matter. It was stated that high ranking government officials had assured that there should not be further problem with regard to the detention of any shipment of their products.

The flyer provided instructions to customers regarding detention of their shipments as follows: "If you have had your products detained by the Miami Customs Office and/or the Miami FDA, please send us the FDA form that you received notifying you of the detention of your products. As soon as we receive this form, we will reship your products immediately."

The flyer presented false allegations regarding FDA rulings, receipt of formal complaints, and assurances by high ranking government officials.

Based on labeling, the drugs are misbranded because they lack adequate directions for use and include false and misleading claims. The drugs are limited to prescription use and may be potentially lethal if improperly administered, taken without adequate directions for use, or administered without the supervision of a licensed practitioner.

Detention activity continues under this import alert as evidenced by 427 and 410 detentions reported for FY92 and FY93, respectively.

ORL-DO reported that some shipments of Minoxidil had been received in unlabeled bottles. Stick on labels for Minoxidil, instructions for use, and in some cases, a prescription, had been subsequently provided by the Heitzinger Pharmacy which also uses the same mail drop address as the Hauptmann Institute.

Further, ORL-DO reported that a flyer had been distributed by The Hauptmann Institute to customers in the states of Florida and Georgia alleging that FDA had detained these drugs illegally based on "the

FDA ruling that permits individuals to bring unapproved drugs into the United States for personal use". It was contended that The Hauptmann Institute had filed a formal complaint and that FDA had not yet issued a formal order regarding this matter. It was stated that high ranking government officials had assured that there should not be further problem with regard to the detention of any shipment of their products.

The flyer provided instructions to customers regarding detention of their shipments as follows: "If you have had your products detained by the Miami Customs Office and/or the Miami FDA, please send us the FDA form that you received notifying you of the detention of your products. As soon as we receive this form, we will reship your products immediately."

The flyer presented false allegations regarding FDA rulings, receipt of formal complaints, and assurances by high ranking government officials.

Based on labeling, the drugs are misbranded because they lack adequate directions for use and include false and misleading claims. The drugs are limited to prescription use and may be potentially lethal if improperly administered, taken without adequate directions for use, or administered without the supervision of a licensed practitioner.

Detention activity continues under this import alert as evidenced by 427 and 410 detentions reported for FY92 and FY93, respectively.

Guidance:

Discticts may detain, without physical examination, the drug products, including promotional materials, identified in the Red List, as these are known to be associated with The Hauptmann Institute. Shipments of these drugs may be made by The Hauptmann Institute, Heitzinger Pharmacy, or other shippers from countries other than Austria.

Since these drugs are provided by The Hauptmann Institute throughout the United States, we believe they continue to come through all ports of entry processing airmail from Europe.

Districts should provide a copy of this revised alert to Customs and continue cooperation with Customs to detain entries.

As districts encounter shipments of new drugs which should be included in the Red list of this alert, the information, including the label/labeling and any accompanying promotional materials, should be forwarded to the Division of Import Operations and Policy, HFC-170.

Product Description:

All known drugs from The Hauptmann Institute

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA) [Unapproved New Drug, Section 505(a);"

OASIS Charge Code - UNAPPROVED

And

"it appears to be misbranded in that it lacks adequate directions for its intended use [Misbranding, Section 502(f)(1)]."